QA Academic CMC Development

Lundbeck

København
Permanent
Fuldtid

1 måned siden

QA Academic CMC DevelopmentDo you want to be part of an agile, inspiring, and competent team while restoring brain health for patients worldwide? Then join us as our new QA Academic, ensuring product quality while collaborating with multiple stakeholders leveraging your professional and personal competencies. We offer an exciting job with a broad variety in you daily work supporting CMC deliverables from early to late phase pipeline projects.Your new role – why is this a great opportunity?As our new colleague, you will support the progression of our Small Molecule R&D pipeline of promising drug candidates, by adequate QA oversight and support of the CMC deliverables related to the internally and outsourced API manufacturing including the related QC activities.In the job you will approve documentation related to Small Molecule manufacturing and QC activities such as API master batch records, batch records, specifications, and qualifications. You will release Raw materials, starting materials, intermediates, API including approval of deviations, change controls and laboratory deviations. You will contribute to our continued development of the Quality Management System by authoring and approving SOP´s governing the activities.You will join a great team working closely together in a flexible manner balancing workload. The job offers great opportunities to grow your competencies and knowledge and to widen your duties and responsibility as you develop in the role.Your future teamThe CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle who together are responsible for efficient and compliant quality processes in support of the development of Small Molecule- and Biologics drug candidates – incl. device activities.You will join a QA Department of 6 QA colleagues located in Copenhagen and will be working primarily in DK time zone. The team holds the QA responsibility for internal and external development activities across projects and activities. You will be part of a dedicated and collaborative team, where the culture is characterized by an open, trust-based, and supportive working environment. We enjoy learning every day and thrive in the dynamic CMC environment. We have fun, acknowledge each other, and live by the thought that when we support one another, everybody wins.We offer a unique position for you to build upon your experiences and professional development. Your dedication is crucial. Therefore, you can expect us to be committed to your progress, so you can stay committed to ours.What you bring to the team

You hold a master’s degree in either: Pharmacy/Chemistry/Engineering or similar
4-5 years of experience in a GMP regulated environment preferably in Manufacturing, Quality Control or Quality Assurance
Knowledge and competencies within organic and analytical chemistry
A solid understanding of GMP requirements
You are fluent in both Danish and English

Applicants must be in commuting distance of Lundbeck Headquarter in Copenhagen with visits at our site in Lumsås, Sjællands Odde 1-3 times monthly.Our promise to youLundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.You can also learn more about us at or by following us on LinkedIn or Instagram (@h_lundbeck).Apply nowCan you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.If you have questions or want to hear more, please feel free to contact Director CMC Development QA – Charlotte Ullits Houlbjerg via phone +45 3083 21 69. Applications must be received by April 30th, 2024. Application review and interviews will be conducted on an ongoing basis. The position might be unposted before the deadline as we find the best candidate.We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at .#EveryBrainInTheGameThis job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

Lundbeck

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